SHENYI SHANDONG PLASTIC PRODUCTS CO LTD

FDA Device Registration & Listing · Linzi Shandong, CN · Registration 3011786252

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011786252
FEI Number
3011786252
Entity Name
SHENYI SHANDONG PLASTIC PRODUCTS CO LTD
City/State/Country
Linzi Shandong, CN
Establishment Address
23 Fenghuang Road,Fengshan Industry Park, Linzi Shandong 255400, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenyi Shandong Plastic Products Co Ltd (Owner Number: 10049482)
Owner / Operator Contact Address
23 Fenghuang Road, Fengshan Industry Park, Linzi, CN-SD 255400, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K091942
PMA Number
N/A

All Registered Proprietary Names

Vinyl Exam Gloves, PF Vinyl patient examination glove Vinyl Exam Gloves, PF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2015-06-05
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2023-09-21
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2026-02-04
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2018-08-17

Official Correspondent

Ray Zhou

US Agent Details

Max Lee Business: Primemax Email: maxli@basicmedical.com Phone: (909) 9801678

Related Public Records

Same Entity

Shenyi Shandong Plastic Products Co Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K052612 Shanghai Antares Industries, Inc. DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR 2005-11-22
K120584 Wealth on (Jiangsu) Co., Ltd. POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES 2012-07-10
K220992 Ever Global (Vietnam) Enterprise Corporation Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple 2022-10-19
K112610 Inpro Technology Device Factory SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) 2011-12-05
K131340 Made Plastic Co., Ltd. POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES 2014-09-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011786252. Last updated year: 2026. Please use registration number 3011786252 when referencing this establishment in official correspondence.
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